Solutions to three (3) of the most common problems in your Quality Management System (QMS)

Author: Mayra I. Rosa-Pagan, Lead Consultant

Within the Quality Management System there are several important elements to demonstrate the effectiveness implementation towards customer satisfaction. Also, there are fundamental requirements to show compliance to regulatory requirements at all times. Following are the of the most common problems we faced in the QMS and several proposed solutions to help on tackling those down.

1. CAPA

Inadequate CAPA records are a symptom of inefficient quality controls and the preamble of regulatory compliance issues.

Solutions to avoid compliance concerns you must:

1. Establish a well-defined procedure for root cause investigations and analysis.
2. Implement a CAPA Review Board that will have responsibility to oversee the CAPA process and well-documented records from issuance, progress up to the closure of effectively implemented corrective actions.
3. Promote preventive actions to avoid quality issues to occur and foster continuous improvement programs.

2. Management Review and Data Analysis

A Robust management decision program is based on sound and complete data analysis

Solutions to avoid compliance concerns you must:

1. Establish procedures for data collection and trend analysis with sound statistical justification and solid documentation of the results
2. Implement periodic reviews based on business units, processes or product lines to address specific indicators not meeting the goals
3. Maintain general review meetings to analyze overall quality performance within specific intervals (monthly, quarterly and annually)

3. Training

Lack of adequate training and development activities is the beginning of potential failures in the quality management system.

Solutions to avoid compliance concerns you must:

1. Establish procedures that define training requirements for every job position in the organization
2. Ensure training is revised within periodic intervals to guarantee personnel is current on their skills and knowledge
3. Promote various learning methods such as, classroom, online and workshop learning activities that will enhance the process to strengthen the employee’s abilities and expertise.

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